MISTIE INTRACEREBRAL HEMORRHAGE TRIAL

Does faster clot removal in ICH give better patient outcomes?

115 Sites to Qualify:
115
90 Sites to Activate:
77
500 Participants to Enroll:
407

On the Road to MISTIE III - EDC Form Design Considerations

The June MISTIE III webinar focused on one of the most important tasks in preparing for the launch of the trial this fall -- designing the electronic data capture (EDC) system forms.  Steve Mayo gave a presentation reviewing the form designs from the prior MISTIE and CLEAR trials and the considerations that are currently going into designing the online case report forms for MISTIE III.

Coordinators are invited to get involved in these early planning efforts and provide suggests for how to optimize and simplify data collection for this new trial.

 

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MISTIE-II 365-Day Results Presented at 2013 International Stroke Conference

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Dr. Daniel Hanley, co-principal investigator for the MISTIE clinical trial, was a featured speaker this week at the 2013 International Stroke conference (ISC) in Honolulu as he presented 365-day results from this phase-II clinical trial. MISTIE is an acronym for Minimally Invasive Surgery + rt-PA for Intracerebral Hemorrhage (ICH) Evacuation. ICH is a type of stroke caused by bleeding within the brain, often the result of uncontrolled hypertension. It is also referred to as cerebral stroke or hemorrhagic stroke.

This recently-completed proof-of-concept trial evaluated the use of tPA (a thrombolytic or clot-busting drug) delivered via a catheter placed under CT (a series of x-ray images) guidance. Data from the 123 patients enrolled across 26 medical centers provides ground-breaking evidence, which now needs to be verified in a larger phase-III trial, that this technique offers future promise for reducing the high rate of death and serious disability in ICH patients. Preliminary results were presented at last year's conference. Now that study participants have reached the one-year mark, the final results are even more encouraging. A summary of these results have been published on the American Stroke Society's ISC website -- scroll to the bottom to see Dr. Hanley's late-breaking presentation materials.

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Aloha! BIOS at the International Stroke Conference!

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Aloha Friends! In just a few short days, we will be in sunny Honolulu at the International Stroke Conference. During the conference this year, we have many exciting programs and presentations about the findings from MISTIE II and future plans for MISTIE III. Continue reading for details on all events. We hope to see you there!

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On the Road to MISTIE III

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The last patient has now completed in Stage II of the phase II MISTIE trial and the final patient in the endoscopy tier should reach the one-year follow-up endpoint next spring. We now turn to data analysis and publication of final results in this trial of minimally-invasive approaches to intracerebral hemorrhage (ICH). Meanwhile, we are already on the road to a phase III trial!

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MISTIE-ICES Trial Closed to Enrollments!

Earlier this month, on April 3, PI: Alan Hoffer and Coordinator: Val Cwiklinski at Case Western Reserve University Hospital enrolled the last MISTIE-ICES subject, therefore closing the trial to enrollments!  The MISTIE-ICES Trial opened in mid-2008 and has since enrolled 20 subjects across five centers: Barrow Neurological Institute, Case Western Reserve University Hospital, University of California, Los Angeles, University of California, San Diego and the University of Pittsburgh Medical Center.

The MISTIE-ICES Trial is the 3rdtier in Stage I of the MISTIE Trial.  The purpose of the MISTIE-ICES Trial is to determine the safety of using either endoscopic surgery (ICES) or a combination of minimally invasive surgery and clot lysis with rt-PA (MISTIE) to remove intracerebral hemorrhage.  The ICES arm is led by Drs. Paul Vespa and Neil Martin at the University of California, Los Angeles and Dr. Dan Hanley at Johns Hopkins University.

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Brain Injury Outcomes

Johns Hopkins University
1550 Orleans Street
CRB-II, 3M50 South
Baltimore, MD 21231 USA
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